AZACITIDINE
Generic: AZACITIDINE
Meitheal Pharmaceuticals Inc.Manufacturer
INTRAVENOUS, SUBCUTANEOUSRoute
AZACITIDINEActive Substance
2020-11-02Original Approval
AZACITIDINE is FDA application ANDA212128, sponsored by MEITHEAL. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2022-07-22
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint LaSubpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for As
Class II2020-12-08
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, CytotoxCGMP Deviations
Class III2022-01-19
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 Failed stability specifications
Class III2022-01-19
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 0Failed stability specifications
Top Reported Reactions
1
FEBRILE NEUTROPENIA
1,996 reports
2
DEATH
1,848 reports
3
OFF LABEL USE
1,528 reports
4
MYELOSUPPRESSION
1,502 reports
5
NEUTROPENIA
1,359 reports
6
ACUTE MYELOID LEUKAEMIA
1,299 reports
7
PNEUMONIA
1,058 reports
8
DRUG INEFFECTIVE
1,007 reports
9
PYREXIA
998 reports
10
THROMBOCYTOPENIA
983 reports